Introduction to Clinical Trial Disclosure

Clinical Trial Disclosure is a compliance requirement that faces life sciences organizations around the world. The complexity of working with evolving health authority requirements and managing dynamic clinical trial data on a global basis can be significant. It is important to understand the context of disclosure in order to appreciate the rationale for registering clinical trials and reporting trial results. This paper offers a brief history of regulations, an overview of requirements and a discussion of the consequences of noncompliance.